Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
134 participants
INTERVENTIONAL
2025-09-12
2026-09-01
Brief Summary
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Researchers will compare application of device RADA16 to application of no device to see if RADA16 works to treat post tonsillectomy hemorrhage.
Participants will:
* Undergo tonsillectomy procedure.
* Receive and fill out a survey sent via email every 2 days following their procedure for 15 days and track their symptoms.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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RADA16
Patients randomized to the treatment arm will undergo application of 2.5% RADA16 hydrogel to the tonsillar fossae following tonsillectomy using a sterile syringe tip applicator. The gel will be spread into a thin layer within the tonsillar fossae. The gel will be left to sit for 60 seconds. A suction device will then be used to remove any excess RADA16 hydrogel, leaving a thin layer of RADA16 over the tonsillar fossae.
RADA16 hydrogel
Application of 2.5% RADA16 hydrogel to the tonsillar fossae following tonsillectomy using a sterile syringe tip applicator. The gel will be spread into a thin layer within the tonsillar fossae. The gel will be left to sit for 60 seconds. A suction device will then be used to remove any excess RADA16 hydrogel, leaving a thin layer of RADA16 over the tonsillar fossae.
Control arm
Patients randomized to the control arm will not undergo application of RADA16 hydrogel following hemostasis with suction monopolar electrocautery.
No interventions assigned to this group
Interventions
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RADA16 hydrogel
Application of 2.5% RADA16 hydrogel to the tonsillar fossae following tonsillectomy using a sterile syringe tip applicator. The gel will be spread into a thin layer within the tonsillar fossae. The gel will be left to sit for 60 seconds. A suction device will then be used to remove any excess RADA16 hydrogel, leaving a thin layer of RADA16 over the tonsillar fossae.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
Patients who have had prior tonsillectomy or tonsillotomy
Patient undergoing tonsillectomy with concern for malignancy
Patients who are on opioids chronically prior to surgery
Patients with an additional indication for pain management (i.e. unrelated to tonsillectomy)
Patients who have been diagnosed with a bleeding disorder or hematologic malignancy
Patients who are on anticoagulants
The following at-risk populations:
Anyone under age 18
Pregnant women
Prisoners
Adults unable to consent (anyone lacking capacity)
18 Years
ALL
No
Sponsors
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Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Wayne Daniel Hsueh, MD
ASSOC PROF-CLIN
Principal Investigators
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Wayne D Hsueh, MD
Role: PRINCIPAL_INVESTIGATOR
Rutgers University
Locations
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Cooperman Barnabas Medical Center
Livingston, New Jersey, United States
University Hospital
Newark, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Gabriel Frimpong, MPH, PA
Role: primary
Gabriel Frimpong, MPH, PA
Role: primary
References
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Pynnonen M, Brinkmeier JV, Thorne MC, Chong LY, Burton MJ. Coblation versus other surgical techniques for tonsillectomy. Cochrane Database Syst Rev. 2017 Aug 22;8(8):CD004619. doi: 10.1002/14651858.CD004619.pub3.
Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
Mitchell RB, Archer SM, Ishman SL, Rosenfeld RM, Coles S, Finestone SA, Friedman NR, Giordano T, Hildrew DM, Kim TW, Lloyd RM, Parikh SR, Shulman ST, Walner DL, Walsh SA, Nnacheta LC. Clinical Practice Guideline: Tonsillectomy in Children (Update). Otolaryngol Head Neck Surg. 2019 Feb;160(1_suppl):S1-S42. doi: 10.1177/0194599818801757.
Other Identifiers
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FP00039655
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Pro2024001000
Identifier Type: -
Identifier Source: org_study_id